Myocardial Injury and Quality of Life After COVID-19

COVID-19 Clinical Trial

Official title:

Myocardial Injury and Quality of Life in Patients Recovered From the Pneumonia Associated With the Novel Coronavirus Infectious Disease COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04794062
• Other study ID #: 08092020
• Status: Completed
• Start date: September 16, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2024
• Source: Voronezh Regional Clinical Consultative and Diagnostic Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this observational study follow-up and dynamic observation will be conducted on the participants recovered from pneumonia caused by COVID-19. The main goal is an early diagnosis and detection of myocardial (heart) injury and quality of life in participants recovered from COVID-19 and follow-up in selected participants with present signs of myocarditis and/or myocardial fibrosis.

Description:

The main goal of this observational non-interventional study is the evaluation of prevalence of myocardial injury (heart injury) of the participants recovered from the novel coronavirus infectious disease (COVID-19). Participants with signs of myocarditis (pericarditis) and/or myocardial fibrosis, and with a threat of heart failure development and other outcomes are selected into this study. In this cohort the percentage of participants having myocardial injury based on the level of high-sensitivity troponin, echocardiography (decreased Left Ventricle Ejection Fraction, abnormalities of wall motion, Right Ventricle dysfunction, increased size of heart chambers above referential values, presence of pericardial effusion), cardiac MRI with contrast enhancement (presence of edema on T2-weighted images, presence of early and late gadolinium enhancement phenomenon, local motion abnormalities, increased size of heart chambers above referential values, presence of pericardial effusion). At 6 months of the dynamic follow-up, MRI with contrast enhancement will be repeated in the participants with established myocardial injury at inclusion to assess the percentage of the participants having ongoing myocardial injury.

The secondary goal of the study is evaluation of quality of life of the patients recovered from the novel coronavirus infectious disease (COVID-19) by the means of EQ-5D and/or DASI questionnaire using the descriptive system of 5 components of quality of life related to the wellbeing, and visual analogue scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 31, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients of age above 18 years with diagnosed SARS-CoV-2 infection based on the PCR (polymerase chain reaction) and/or quantitative tests of IgM and IgG antibodies in serum;

• Pneumonia development confirmed by chest computed tomography;

• Negative PCR test for SARS-CoV-2 at the time of inclusion into the study;

• Stable patient state allowing outpatient follow-up;

• Signed informed consent.

Exclusion Criteria:

• Absence of convincing data confirming SARS-CoV-2 infection of a participant at the time of inclusion;

• Absence of medical records regarding previous treatment of COVID-19;

• Low compliance and unwillingness to undergo defined examinations;

• Absence of informed consent.

Related Conditions & MeSH terms

• COVID-19
• Myocardial Injury
• Myocarditis
• Myocarditis Post Infection
• Wounds and Injuries

Locations

Country	Name	City	State
Russian Federation	Voronezh Region Clinical, Consultative and Diagnostic Center	Voronezh	Voronezh Region

Sponsors (3)

Lead Sponsor	Collaborator
Voronezh Regional Clinical Consultative and Diagnostic Center	Charles University, Czech Republic, Voronezh State Medical University named after N.N. Burdenko

Country where clinical trial is conducted

Russian Federation, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients (%) Recovered From COVID-19 With a Decrease in the Global Contractility of the Left and Right Ventricles.	Decrease of the left ventricle ejection fraction below 57% in men and women or decrease of the right ventricle ejection fraction below 52% in men and 51% in women.	Up to 12 months
Primary	Proportion of Patients (%) Recovered From COVID-19 With Signs of Pericardial Effusion.	Presence of pericardial effusion, i.e., presence of free echocardiographic spaces between the pericardial layers during diastole with pericardial layer thickness more than 4mm.	Up to 12 months
Primary	Proportion of Patients (%) Recovered From COVID-19 With Signs of Early and Late Gadolinium Enhancement of Myocardium.	Presence of early and late gadolinium enhancement of myocardium on cardiac MRI.	Up to 12 months